MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SYNGO IMAGING XS; PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

Model Number 10496279

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/15/2016

Event Type  malfunction  

Manufacturer Narrative

Resubmission of initial report as per fda on 7/28/20.There are no injuries attributed to the reported event.However, the investigation whether clinically relevant data loss occurred is on-going.The amount of data loss is currently unknown.Activities are ongoing at site to evaluate the amount of data lost and after those activities are finished the amount of data lost will be known.This activity will take several weeks.This report was submitted january 19, 2017.Customer's address: (b)(6).

Event Description

Since 2010, the image archive is done in one nas (network attached storage), which is attached to the syngo imaging xs server.On (b)(6), the nas system crashed suddenly and after a restarted, one of the logical drives disappeared from the operating system.The drive has been re-enabled and during the investigations it was identified that several zip files containing the patient studies are corrupted.The reported event occurred in (b)(6).

• Brand Name: SYNGO IMAGING XS
• Type of Device: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, 91052 ; GM 91052
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; mc 65-1a; malvern, pa ; 4486478
• MDR Report Key: 7075432
• MDR Text Key: 243718915
• Report Number: 2240869-2017-65147
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K082430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10496279
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/21/2016
• Initial Date FDA Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other